Intra-cranial objective response rate in breast cancer patients with brain metastasis [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]

Number of patients with adverse events as a measure of safety and tolerability of GRN1005 alone or in combination with Trastuzumab [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: Yes ]

Intra-cranial objective response duration [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]

3-month intra-cranial progression-free survival [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]

Six month overall survival (OS) [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ICMJE

Same as current

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases

The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from breast cancer. For patients with HER2 positive metastatic breast cancer, GRN1005 will be assessed in combination with Trastuzumab (Herceptin®) as per standard-of-care practice.

In addition, this study will evaluate the ability of 18F-FLT to determine if the amount of change in the uptake in the brain metastases from breast cancer after GRN1005 treatment, correlates with intra-cranial response (for patients enrolled at NCI).

GRN1005 alone in HER2- MBC patients with brain mets. 18F-FLT may also be administered to this arm (if patient enrolled at NCI)

Interventions:

Drug: GRN1005

Drug: 18F-FLT

Experimental: GRN1005 with trastuzumab

GRN1005 in combination with trastuzumab in MBC patients with brain mets 18F-FLT may also be administered to this arm (if patient enrolled at NCI)

Interventions:

Drug: GRN1005

Drug: Trastuzumab

Drug: 18F-FLT

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

85

Completion Date

October 2015

Primary Completion Date

June 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Key Inclusion Criteria:

Age ≥ 18 years

Histologically or cytologically-documented breast cancer (HER2 status and ER/PgR status must be known)

Brain metastasis from breast cancer with or without prior WBRT

At least one radiologically-confirmed and measurable metastatic brain lesion (≥ 1.0 cm in the longest diameter) by Gd-MRI of the brain < 14 days prior to first dose (Metastatic brain lesions previously treated with SRS may not be target or non-target lesions)

Patients must be neurologically stable: On stable doses of corticosteroids and anticonvulsants (not EIAEDs, including phenytoin, phenobarbitol, carbamazepine, fosphenytoin, primidone, oxcarbazepine) for ≥ 5 days prior to obtaining the baseline Gd-MRI of the brain and ≥ 5 days prior to first dose

KPS ≥ 70%

Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose